Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

NCT ID: NCT01707134

Last Updated: 2017-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

753 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2000-05-31

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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insulin aspart

Group Type EXPERIMENTAL

insulin aspart

Intervention Type DRUG

Injected subcutaneously (s.c, under the skin) as meal time insulin

insulin NPH

Intervention Type DRUG

Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin

human insulin

Group Type ACTIVE_COMPARATOR

human soluble insulin

Intervention Type DRUG

Injected subcutaneously (s.c, under the skin) as meal time insulin

insulin NPH

Intervention Type DRUG

Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin

Interventions

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insulin aspart

Injected subcutaneously (s.c, under the skin) as meal time insulin

Intervention Type DRUG

human soluble insulin

Injected subcutaneously (s.c, under the skin) as meal time insulin

Intervention Type DRUG

insulin NPH

Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject must have completed the six month controlled treatment period in trial ANA/DCD/035
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR,1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Graz, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

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Novo Nordisk Investigational Site

Vienna, , Austria

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Novo Nordisk Investigational Site

Copenhagen, , Denmark

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Frederiksberg, , Denmark

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Novo Nordisk Investigational Site

Gentofte Municipality, , Denmark

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Kolding, , Denmark

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Køge, , Denmark

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Helsinki, , Finland

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Kotka, , Finland

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Kuopio, , Finland

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Vantaa, , Finland

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Bad Neuenahr-Ahrweiler, , Germany

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Bad Oeynhausen, , Germany

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Bochum, , Germany

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Essen, , Germany

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Essen, , Germany

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Flensburg, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Friedrichsthal, , Germany

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Giessen, , Germany

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Haan, , Germany

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Hamburg, , Germany

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Kiel, , Germany

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Magdeburg, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Mainz, , Germany

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Mönchengladbach, , Germany

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München, , Germany

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Oberhausen, , Germany

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Ostercappeln, , Germany

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Saarlouis, , Germany

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Schwerin, , Germany

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Stuttgart, , Germany

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Stuttgart, , Germany

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Wiesbaden, , Germany

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Wuppertal, , Germany

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Würzburg, , Germany

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Bergen, , Norway

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Haugesund, , Norway

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Oslo, , Norway

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Stavanger, , Norway

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Trondheim, , Norway

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Falun, , Sweden

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Karlstad, , Sweden

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Zurich, , Switzerland

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Airdrie, , United Kingdom

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Bath, , United Kingdom

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Blackburn, , United Kingdom

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Bolton, , United Kingdom

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Church Village, , United Kingdom

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Cosham, , United Kingdom

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Coventry, , United Kingdom

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Edinburgh, , United Kingdom

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Edinburgh, , United Kingdom

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Exeter, , United Kingdom

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Gillingham, , United Kingdom

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Hull, , United Kingdom

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Inverness, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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Middlesbrough, , United Kingdom

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Newcastle, , United Kingdom

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Northampton, , United Kingdom

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Nottingham, , United Kingdom

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Penarth, , United Kingdom

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Plymouth, , United Kingdom

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Reading, , United Kingdom

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Rugby, , United Kingdom

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Salisbury, , United Kingdom

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Sheffield, , United Kingdom

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Southampton, , United Kingdom

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Stevenage, , United Kingdom

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Stirling, , United Kingdom

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Swansea, , United Kingdom

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Watford, , United Kingdom

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Whiston, , United Kingdom

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York, , United Kingdom

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Countries

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Austria Denmark Finland Germany Norway Sweden Switzerland United Kingdom

References

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Home PD, Hallgren P, Usadel KH, Sane T, Faber J, Grill V, Friberg HH. Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes. Diabetes Res Clin Pract. 2006 Feb;71(2):131-9. doi: 10.1016/j.diabres.2005.05.015. Epub 2005 Jul 27.

Reference Type RESULT
PMID: 16054266 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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ANA/DCD/050

Identifier Type: -

Identifier Source: org_study_id

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